[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603678":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":22,"studyPopulation":22,"armGroups":41,"interventions":54,"overallOfficials":22,"centralContacts":64,"locations":22,"responsibleParty":70,"collaborators":74,"id":87,"slug":22,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":22,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":22,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":112,"whyStopped":22,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":22},{"fullName":5,"class":6},"Affiliated Hospital of Shandong University of Traditional Chinese Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Ulcer Recurrence Rate","Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers \u002F Total Subjects) × 100%","Measured at 6 months post-intervention",[14,16,20,24,28],{"measure":10,"description":11,"timeFrame":15},"Ulcer recurrence rates at 3, 9, and 12 months post-intervention",{"measure":17,"description":18,"timeFrame":19},"Calculation of ulcer recurrence episodes","Recurrence is counted based on the timing of occurrence. Ulcers appearing concurrently at distinct anatomical sites are counted as one episode; those occurring at different time points are counted as multiple episodes.","Assessed at 6 months post-intervention",{"measure":21,"description":22,"timeFrame":23},"Ankle-Brachial Index",null,"6 and 12 months after intervention",{"measure":25,"description":26,"timeFrame":27},"TCM Syndrome Score","TCM Syndrome Scoring Scale Description\n\nThis scale quantifies six core manifestations of Qi Stagnation and Blood Stasis Syndrome in diabetic lower extremity arterial disease, using a four-tier scoring system (0\u002F2\u002F4\u002F6 points):\n\nLimb coldness: Asymptomatic (0 pts); Occasional, self-relieved (2 pts); Persistent, relieved by warmth (4 pts); Persistent, unrelieved by warmth (6 pts)\n\nLimb pain: None (0 pts); Mild (2 pts); Moderate (4 pts); Severe (sleep-disturbing) (6 pts)\n\nChest\u002Fabdominal distension: Absent (0 pts); Occasional mild (2 pts); Frequent moderate (4 pts); Frequent severe (6 pts)\n\nSkin temperature: Normal (0 pts); Slightly decreased (2 pts); Significantly decreased (4 pts); Cold (6 pts)\n\nIntermittent claudication: Absent (0 pts); Distance \\>500 meters (2 pts); 200-500 meters (4 pts); ≤200 meters (6 pts)\n\nFoot coloration: Normal (0 pts); Dark red (2 pts); Pale\u002Fpurplish-dark (4 pts); Cyanosis\u002Fecchymosis (6 pts)","at 3 and 6 months post-intervention",{"measure":29,"description":22,"timeFrame":30},"Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality","3, 6, 9, and 12 months after intervention",{"allocation":32,"interventionModel":33,"interventionModelDescription":22,"primaryPurpose":34,"observationalModel":22,"timePerspective":22,"maskingInfo":35},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":36,"maskingDescription":22,"whoMasked":37},"TRIPLE",[38,39,40],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Experimental Arm","EXPERIMENTAL","Background Therapy Strict dietary control\n\nStandardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines\n\nIndividualized antithrombotic regimen:\n\n* First-line: Aspirin 100mg\u002Fd\n* Alternative: Clopidogrel 75mg\u002Fd or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Experimental Arm Background therapy + Guanxinning Tablets",[47],"Drug: Guanxinning Tablets",{"label":49,"type":50,"description":51,"interventionNames":52},"Placebo Arm","PLACEBO_COMPARATOR","ackground Therapy Strict dietary control\n\nStandardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines\n\nIndividualized antithrombotic regimen:\n\n* First-line: Aspirin 100mg\u002Fd\n* Alternative: Clopidogrel 75mg\u002Fd or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Placebo Arm Background therapy + Matching Placebo for Guanxinning Tablets",[53],"Drug: Matching Placebo for Guanxinning",[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":22},"DRUG","Guanxinning Tablets","Guanxinning Tablets\n\n* Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.\n* NMPA Approval No. Z20150028\n* Administration: 4 tablets orally, three times daily for 6 months",[43],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":22},"Matching Placebo for Guanxinning","Matching Placebo for Guanxinning Tablets\n\n* Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.\n* Drug Product Certificate of Analysis Approval No.YF-R-C037A-2024104-A\n* Administration: 4 tablets orally, three times daily for 6 months",[49],[65],{"name":66,"role":67,"phone":68,"phoneExt":22,"email":69},"Yannan Wang","CONTACT","+86 13791130209","cweiyue@163.com",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Zheng Liu","MD-PhD",[75,77,79,81,83,85],{"name":76,"class":6},"Beijing Shijitan Hospital, Capital Medical University",{"name":78,"class":6},"Peking University Third Hospital",{"name":80,"class":6},"Dongzhimen Hospital, Beijing",{"name":82,"class":6},"Xuanwu Hospital, Beijing",{"name":84,"class":6},"The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine",{"name":86,"class":6},"Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology","100603678",false,"NCT07139639","Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease","Evidence-Based Evaluation and New Drug Development of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease","Inclusion Criteria:\n\n1. Age: 18 to 80 years old (inclusive)\n2. Diagnosis: Confirmed type 1 or type 2 diabetes mellitus\n3. Meeting diagnostic criteria for diabetic lower extremity arterial disease (DLEAD)\n4. TCM Syndrome: Qualified for Qi Stagnation and Blood Stasis syndrome pattern\n5. Glycemic Control:\n\n   * HbA1c ≤9% or Fasting plasma glucose ≤10 mmol\u002FL\n6. Ulcer History:\n\n   * Documented history of diabetic lower extremity arterial disease (DLEAD)-related ulcers, with confirmed healing (wound re-epithelialization without signs of redness, purulent discharge, or infection) 2-8 weeks prior to enrollment.\n7. Consent: Voluntarily signed informed consent form\n\nExclusion Criteria:\n\n* (1) Ulcer Etiology Exclusion:\n* Pure pressure ulcers\n* Pure neuropathic ulcers\n* Immune-mediated ulcers (e.g., vasculitic ulcers caused by lupus, Behcet's disease, rheumatoid arthritis) (2) Recent Cardiovascular Events:\n* Acute coronary syndrome within 3 months\n* Hemorrhagic stroke within 3 months (3) Organ Dysfunction:\n* Severe hepatic impairment (AST or ALT \\>1.5×ULN)\n* Chronic kidney disease stage 4-5 (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²) (4) Recent Major Bleeding:\n* Gastrointestinal hemorrhage within 1 month (5) Concurrent TCM Therapy:\n* Use of blood-activating\u002Fstasis-resolving TCM preparations for DLEAD within 1 week (6) Herbal Contraindication:\n* Concurrent or planned use of \\*Veratrum\\*-containing preparations (7) Malignancy:\n* Active cancer progression (8) Reproductive Status:\n* Pregnant or lactating women (9) Allergy History:\n* Known hypersensitivity to \\*Ligusticum chuanxiong\\* or \\*Salvia miltiorrhiza\\* (10) Cognitive\u002FLanguage Barriers:\n* Psychiatric disorders\n* Intellectual\u002Flanguage impairment affecting scale completion\n* Unwillingness to cooperate (11) Life Expectancy:\n* \\\u003C1 year (12) Clinical Trial Participation:\n* Enrollment in other drug trials within 1 month (13) Investigator's Discretion:\n* Other conditions deemed unsuitable for participation","ALL","18 Years","80 Years",{"count":97,"type":98},350,"ESTIMATED","INTERVENTIONAL",[101],"EARLY_PHASE1","Taking the approach of promoting qi circulation and activating blood as the entry point, this study targets lower extremity arterial disease（LEAD） patients with TCM syndrome pattern of blood stasis due to qi stagnation. Using Guanxinning Tablets (a herbal formula with qi-moving and blood-activating properties) as the investigational medication, we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the classic herb pair (Chuanxiong Rhizoma-Salviae Miltiorrhizae) in preventing LEAD ulcer recurrence. This research aims to accumulate evidence-based medical data supporting new drug development.",[104],"Diabetic Lower Extremity Arterial Disease",[106,107,108,109,57,110,111],"Recurrence of ulcer","Diabetic Lower extremity arterial disease","Interventional Study","Prevention","Salviae Miltiorrhizae","Chuanxiong Rhizoma","NOT_YET_RECRUITING","2025-08-18",{"date":115,"type":116},"2025-08-24","ACTUAL",{"date":118,"type":98},"2025-11-01",{"date":120,"type":98},"2028-12-01",{"name":72,"class":6}]